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. 2019 Jul 1:9:55-78.
doi: 10.2147/DNND.S208815. eCollection 2019.

Efficacy, safety, and quality-of-life of treatments for acute relapses of multiple sclerosis: results from a literature review of randomized controlled trials

Jessica Costello  1 , Annete Njue  1 , Matthew Lyall  1 , Anne Heyes  1 , Nancy Mahler  2 , Michael Philbin  2 , Tara Nazareth  3
Affiliations

Efficacy, safety, and quality-of-life of treatments for acute relapses of multiple sclerosis: results from a literature review of randomized controlled trials

Jessica Costello et al. Degener Neurol Neuromuscul Dis. .

Abstract

Background: Intravenous methylprednisolone (IVMP), repository corticotropin injection (RCI), plasmapheresis (PMP), and intravenous immunoglobulin (IVIG) are used in the treatment of acute multiple sclerosis (MS) relapse. A systematic literature review (SLR) of randomized controlled trials (RCTs) was conducted to examine the highest quality evidence available for these therapies.

Methods: English-language articles were searched in MEDLINE, Embase, and Cochrane Library through May 2016 per Preferred Reporting Items for Systematic Reviews and Meta-Analyses standards. MS conferences, SLRs, and bibliographies of included studies were also searched. Eligible studies included adults treated with ≥1 aforementioned therapy.

Results: Twenty-three RCTs were identified: 22 on efficacy, 11 on safety, and 3 on QOL (ie 18 IVMP, 2 RCI, 2 PMP, and 2 IVIG). IVMP and RCI improved relapse-related disability; however, IVIG and PMP showed inconsistent efficacy. QOL data were only ascertained for IVMP.

Conclusions: RCTs indicate IVMP and RCI are efficacious and well tolerated treatments for MS relapse. Overall, many RCTs were dated, with sample sizes of fewer than 30 patients and no definitions for relapse nor clinically significant change. Contemporary evidence generation for all relapse treatments of interest, across efficacy, safety, and QOL outcomes, is still needed.

Keywords: efficacy; multiple sclerosis relapse; safety; systematic literature review.

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Conflict of interest statement

Jessica Costello, Annete Njue, Matthew Lyall, and Anne Heyes were employees of RTI Health Solutions at the time this SLR was developed and provided consulting services to Mallinckrodt Pharmaceuticals. Nancy Mahler is an employee of Mallinckrodt Pharmaceuticals. Tara Nazareth and Michael Philbin were employees of Mallinckrodt Pharmaceuticals at the time this work was done. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
PRISMA diagram for study inclusion and exclusion. aA focus on RCTs was imposed at level 2 screening. All other study types were excluded (ie, publications that were duplicates, non-English publications). bOne RCT compared two treatments of interest: IVMP versus PMP. Abbreviations: IVIG, intravenous immunoglobulin; IVMP, intravenous methylprednisolone; PMP, plasmapheresis; RCI, repository corticotropin injection; RCT, randomized controlled trial; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses.
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